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Study Title and Description

The effect of smoking and caffeine on the fetus and placenta in pregnancy.



Key Questions Addressed
1 For [population], is caffeine intake above [exposure dose], compared to intakes [exposure dose] or less, associated with adverse effects on reproductive and developmental outcomes?
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Primary Publication Information
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TitleData
Title The effect of smoking and caffeine on the fetus and placenta in pregnancy.
Author O Balat,A Balat,MG Ugur,S Pençe,
Country
Year 2003
Numbers

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Reproductive Toxicity - Design Details
Arms
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Design Details
Question... Follow Up Answer Follow-up Answer
Refid 12731747
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What outcome is being evaluated in this paper? Reproductive and Development
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What is the objective of the study (as reported by the authors)? The aim of this study was to determine the effects of caffeine consumption and tobacco use on the fetus and placenta. Additionally, their effects on placental diameters were also included in our study which has not been reported in the literature before.
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Provide a general description of the methods as reported by the authors. Information should be extracted based on relevance to the SR (i.e., caffeine related methods) Women with 37 to 41 week-old pregnancies who had spontaneous vaginal deliveries were included in this prospective study. Daily caffeine intake (mg/day) was obtained from average daily consumption of tea and coffee as cup(s) (method not described). The amount of caffeine per cup of coffee and tea was calculated as 107 mg and 34 mg, respectively. Two main groups were chosen in the study: Group I: A total of 63 non smokers pregnant were separated into two subgroups according to their daily caffeine intake; less than 300 mg (la) (n = 44), and more than 300 mg (Ib) (n = 19). Group Il: 60 pregnant smokers (<10 cigarettes/day) were also separated into two subgroups; a daily caffeine intake less than 300 mg (Ila) (n = 43), and more than 300 mg (IIb) (n = 17). Ali newboms and placentas of these patients were examined. The body weights, lengths, and head circumferences of the newborns and also weights and diameters of placentas were measured.
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How many outcome-specific endpoints are evaluated? 2
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What is the (or one of the) endpoint(s) evaluated? (Each endpoint listed separately) Body weights, lengths, and head circumferences of the newborns
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List additional health endpoints (separately).
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List additional health endpoints (separately)
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Notes
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Clinical Clinical
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Physiological
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Other
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What is the study design? Cohort
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Randomized or Non-Randomized?
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What were the diagnostics or methods used to measure the outcome? Objective
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Optional: Name of Method or short description Newborns were weighed naked just after delivery with classic scales. The weights were noted as grams. The head circumferences were measured with a standard paper disposable tape from the occipital prominence projecting over the eyebrows. Obtained values were noted as centimeters. The lengths were measured with a standard paper disposable tape in the supine position. Values were noted as centimeters. Placentas were alI intact after delivery and weighed by classic scales. Obtained values were noted as grams. The weights of the cords were not taken into consideration. The placental diameters were measured in two different axes by a standard paper disposable tape and an average was obtained. Values were noted as centimeters.
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Caffeine (general) Caffeine (general)
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Coffee Coffee
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Chocolate
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Energy drinks
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Gum
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Medicine/Supplement
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Soda
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Tea Tea
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Measured
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Self-report Self-report
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Children
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Adolescents
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Adults
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Pregnant Women Pregnant Women
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What was the reference, comparison, or control group(s)? (e.g. high vs low consumption, number of cups, etc.) <300 mg/day and >300 mg/day caffeine consumption (high vs. low)
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What were the listed confounders or modifying factors as stated by the authors? (e.g. multi-variable components of models.  Copy from methods) None
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Provide a general description of results (as reported by the authors). There was no significant difference among newborn lengths, head circumferences and placental diameters between caffeine groups (p > 0.05). However, differences were statistically significant among weights of newborns and placentas between groups (p < 0.05). These findings were true for bot non-smokers and smokers.
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Did the authors perform a dose-response analysis (or trend/related analysis)? No
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What were the authors's observations re: trend analysis?
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What were the author's conclusions? In conclusion, we detected that caffeine consumption of more than 300 mg per day during pregnancy decreased both placental and newborn weights without any effects on lengths, head circumferences of newborns and placental diameters. Also when smoking was added to caffeine consumption, decreases in the weights of newborns and placentas were more pronounced. We suggest that tobacco use during pregnancy must be prevented both for the health of newborns and mothers, and that also consumption of beverages including caffeine like tea and coffee should be limited during pregnancy,
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What were the sources of funding? None reported
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What conflicts of interest were reported? None reported
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Does the exposure (dose) need to be standardized to the SR? No
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Provide calculations/conversions for the exposure based on the decision tree in the guide (for all endpoints/exposure levels of interest).
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List all the endpoint(s) followed by the dose (mg) which will be used in comparison to Nawrot.  Characterize value as LOAEL/NOAEL, etc. if possible.  LOAEL = >300 mg/day: newborn weight and placental weight NOAEL = >300 mg/day: newborn length, newborn head circumferences, and placental diameter
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Notes regarding selection/listing of endpoints and exposures/doses to be compared to Nawrot. Only 2 comparison groups - < or > 300 mg/day caffeine
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What is the importance of the study with respect to the adverseness of the outcome? Important
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Baseline Characteristics
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Results & Comparisons

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Adverse Events
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